Associate Manager - CMC Regulatory

Overview

Associate Manager, CMC Regulatory works cross-functionally with manufacturing and quality to develop regulatory strategy, oversee submission preparation, and meet reporting requirements for the maintenance of registrations and approvals of new animal drugs with global regulatory agencies.

What you'll do

• Oversee end-to-end lifecycle management (LCM) of small and/or large molecules, complex dosage forms, sterile preparations, biotechnology/fermentation-derived products and specialized dosage forms.
• Design and develop CMC regulatory strategy for marketed products, balancing business benefit with regulatory compliance.
• Maintain positive collaboration and partnership with internal groups in R&D, Quality and Manufacturing, and with global regulatory business partners.
• Lead CMC submission preparation to provide high-quality submissions to multiple geographies.
• Proactively communicate CMC regulatory strategy, key issues and critical topics throughout the lifecycle to interdisciplinary project teams.
• Ensure required documentation and content, quality and timelines for global submissions are communicated to the appropriate teams and tracked according to functional procedures.
• Author high-quality CMC documentation for submission, applying global CMC regulatory strategies and assuring regulatory compliance.
• Keep knowledge current on regulatory guidelines and requirements in all global regions and on new technical trends.
• Provide training and mentorship to CMC team members as necessary.

What you'll need

• Degree in science (MSc, B.Pharm/M.Pharm, postgraduate in Vet Sciences, etc.).
• Strong knowledge of FDA/CVM and EMA guidelines, with an understanding of developing regulatory strategy in other major geographical regions.

Nice to have

• 3 to 5 years in global regulatory affairs, with direct hands-on experience in post-approval CMC lifecycle management.
• Strong knowledge of FDA/CVM, EMA and VICH guidelines.
• Experience with CMC registrations in the US and/or Europe and/or Rest of the World.
• Experience managing multiple pharmaceutical dosage forms.
• Strong written and oral communication skills.
• Ability to make decisions when there is no clear right or wrong answer.
• Self-starter who takes initiative; timeline driven; attention to detail; quality and customer focused.
• Strong organizational skills and ability to handle multiple projects at different phases simultaneously.
• Understanding of cGMP requirements.
• Experience working with Regulatory Information Management tools and systems.

Details

• Location: Bangalore, India.